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CompletedNCT03588767Updated Feb 21, 2023

Endocrine Response of the Organism to Polytrauma

An interventional study of Vitamin D3 + anabolic substance and No Vitamin D3 + anabolic substance in Polytrauma, sponsored by University Hospital Ostrava. Completed at 1 site in Czechia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by University Hospital Ostrava · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled May 2017, registered Jun 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The serious injury causes a complex acute response of the organism to the injury in affected patients, which is manifested in the neuroendocrine, immune and metabolic areas, with an often persisting catabolic state, with a subsequent negative impact upon bone metabolism.

By a timely administration of the D3 vitamin and an anabolic, we attempt to achieve an earlier activation of the anabolic phase of patient resuscitation after serious trauma regarding the monitoring of laboratory values of bone metabolism.

Read the detailed description

Polytrauma and serious complex injuries evoke a vast acute response of the organism to the injury in patients with serious trauma, not only in the form of trauma-haemorrhagic instability; the metabolic response of the organism to trauma also changes, these changes are manifested with activation of integration systems, in the areas of hemocoagulation, as well as changes in the form of changes in the endocrine and immunology systems. The extent of these changes always depends upon the extent and intensity of the mechanism of injury, together with the extent and type of impairment of individual organ systems in the polytraumatized patient.

  1. primarily, due to the extent of the anatomic injury caused by trauma
  2. due to the need to mobilize the reserves in order to repair the impaired tissues
  3. due to the need to activate the main integration systems in the following areas: endocrine, neurological and immunology

Immediately after the injury, the organism reacts to the load with acute phase response, which is characterized with stimulation of the hypothalamus-hypophysis-adrenal glands axis, with activation of the sympathoadrenal system, furthermore with stimulation of synthesis of proteins of the acute phase, activation of the immune system (B-cells and T-cells), activation of neutrophils, fibroblasts, and endothelial cells. At the same time, significant catabolism of proteins occurs, together with changes of levels of various hormones. This pertains primarily to an early decrease of levels of anabolic-acting testosterone, dihydrotestosterone, and free testosterone, and also the total and ionized calcium, high levels of the parathyroid hormone, interleukin-6, cortisol and changes in thyroidal hormones, etc.

At present, substation therapy with an early administration of a substitution dose of vitamin D3 after determination of its level is recommended to treat this endocrine reaction, together with anabolic substances, such as nandrolone decanoate (Deca-Durabolin) already on the first day, while respecting the contraindications, with the aim to reverse the catabolic phase of the polytrauma into the anabolic phase, which, apart from other indicators, influences the parameters of bone metabolism, which may be monitored in the laboratory.

The aim of the study is to verify, whether the administration of substitution vitamin D3 does and anabolic-acting Deca-Durabolin substance (concomitant) from the beginning of the treatment leads to

  1. elimination of bone reabsorption
  2. earlier initiation of the bone remodeling phase in patients affected with a polytrauma, in comparison with a group of similarly traumatized patients from a retrospective file, who did not receive this treatment.

A group of 30 polytraumatized patients with administration of vitamin D3 and Deca-Durabolin anabolic substance will be retrospectively compared to a group of patients treated at the Department of Trauma Surgery, University Hospital Ostrava with ISS>31 in the past years.

Administered substances

  1. Vitamin D3 - Bon 200 000 I.U. i.m. on the first day of trauma, and 3 weeks after trauma, following the verification of 25/OH/ vitamin D value, further substitution of vitamin D in the form of Vigantol 5000I.U. drops administered per os once a week for the period of 6 weeks; the total period of treatment lasting 9 weeks
  2. Anabolic substance - Deca-Durabolin 50mg i.m. on the first day of trauma, a repeated dose of Deca-Durabolin 50mg i.m. 1amp. every 3 weeks; the total period of treatment lasting 9 weeks

Parameters of the bone metabolism and endocrine response will be monitored (telopeptide CTx- beta mass, bone alkaline phosphatase, osteocalcin, type-I procollagen propeptide, bone fraction of alkaline phosphatase, total and ionized calcium, S+U, phosphorus S+U, parathyroid hormone, 25-OH vitamin D, Cortisol S+U , testosterone, dihydrotestosterone, free testosterone, T3, fT4, 17 beta-estradiol/, interleukin 6. These parameters were monitored on the 1st, 7th, 14th, 28th and 70th day.

The results will be analyzed with statistical methods for the purpose of further assessment and evaluation.

02

Conditions studied

  • Polytrauma

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Keywords

  • polytrauma
  • endocrine response
  • metabolic response
  • bone metabolism
  • anabolic substance
  • vitamin D
03

In context

Multiple Trauma

127 studies on the registry are indexed under Multiple Trauma; 28 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 45 interventional studies indexed under Multiple Trauma.

Browse Multiple Trauma studies →

Lead sponsor

University Hospital Ostrava is the lead sponsor of 146 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • serious polytrauma with ISS>31b
  • females, 18-50 years of age
  • males, 18-60 years of age
  • signed informed consent with participation in the study

Exclusion criteria

Exclusion Criteria:

  • infaust craniocerebral injury
  • gravidity
  • lactation
  • prostate cancer
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Vitamin D3 + anabolic substance

    Prospectively enrolled patients with polytrauma, administration of vitamin D3 + anabolic substance

    Drug: Vitamin D3 + anabolic substance

  • Active comparator
    Retrospective analysis

    Retrospectively analyzed patients, no vitamin D3 + anabolic substance administration.

    Other: No Vitamin D3 + anabolic substance

Interventions

  • DrugVitamin D3 + anabolic substance

    Prospectively enrolled patients with polytrauma, administration of vitamin D3 + anabolic substance

  • OtherNo Vitamin D3 + anabolic substance

    Retrospectively analyzed group of patients, no Vitamin D3 + anabolic substance administration

06

What researchers measure

Primary outcomes

  1. Bone metabolism

    Measurement of the P1NP parameter of bone metabolism (earlier bone remodelling): increase of the P1NP parameter over 170% on the 70th day after injury - yes/no

    Time frame: 39 months

Secondary outcomes

  1. Time of healing in patients with multiple fractures

    The time of healing will be assessed in patients with multiple fractures - measured in the number of months until complete healing is confirmed with radio diagnostic examination (X-ray)

    Time frame: 39 months

07

Study locations

1 site
  • University Hospital Ostrava
    Ostrava, Moravian-Silesian Region 708 52, Czechia
08

References and documents

Individual participant data

Plan to share: No — There is no plan to make individual participant data available to other researchers. The data my be provided upon request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03588767
Lead sponsor
University Hospital Ostrava
Responsible party
Sponsor
First posted
Jul 17, 2018
Start date
May 31, 2017
Primary completion
May 30, 2020
Completion
Jan 31, 2021
Last update
Feb 21, 2023

Study contacts

Renáta Ječmínková, MD
principal investigator · University Hospital Ostrava

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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